ORACLE-NIRS: Lipid cORe Plaque Association With CLinical Events: a Near-InfraRed Spectroscopy Study

NCT ID: NCT02265146

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2030-12-31

Brief Summary

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This is a multi-center, investigator initiated study that will prospectively examine treatment strategies and outcomes of patients who underwent clinically-indicated Near Infrared Spectroscopy (NIRS). The information collected will be used to determine the frequency of NIRS imaging performed at the participating sites and to examine the clinical outcomes of the NIRS-detected Lipid Core Plaques (LCPs).

Detailed Description

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Conditions

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Coronary Atherosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1\. Patients who have undergone/ will be undergoing NIRS imaging at each of the participating centers.

Exclusion Criteria

None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanouil S Brilakis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

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North Florida/(South Georgia) VA Health Care System

Gainesville, Florida, United States

Site Status

Atlanta VA Medical Center

Atlanta, Georgia, United States

Site Status

Jesse Brown VA Medical Center

Chicago, Illinois, United States

Site Status

Minneapolis VA Medical Center

Minneapolis, Minnesota, United States

Site Status

VA North Texas Health Care System

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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STU 112013-073

Identifier Type: -

Identifier Source: org_study_id

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